Introduction:

What is Informed Consent?

Informed consent is the
process of communication between a patient and physician
that results in the patient’s authorization or agreement
to undergo a specific medical intervention [AMA 1998]. For
both ethical and legal reasons, patients must be given enough
information to be fully informed before deciding to undergo
a major treatment, and this informed consent must be documented
in writing.

Although this process of patient-physician communication
involves much more than getting a patient to sign a written
consent form (See below: “Informed Consent: It’s
Not About the Form”), it is the very formality
and finality of that signed document that for practical
purposes distinguishes full informed consent from the routine
patient education that occurs in nearly every clinical encounter.
In most institutions, this more formal process requiring
a signature is reserved for surgery, anesthesia, and other
invasive or complex medical or radiologic procedures. Laws
vary from state to state about exactly when and how formal
informed consent must be provided but, national standards
exist as well.

Note that formal informed consent is usually not required
for more common and generally less risky treatments, tests,
and medications. The patient’s consent to these more common
interactions and therapies is generally “implied.”
And for some very basic procedures—like a whole blood
draw—a “basic consent” process involving
a simple description and request for verbal approval may
be adequate. On the other end of the extreme, the informed
consent process for patients volunteering for clinical research
is much more complex, involving special Institutional Review
Boards and close monitoring. [CFR Title 45 1991]

Why this guide?
This publication focuses on ways to improve full informed
consent—both the process and the written forms—as
it is employed in everyday (i.e., NOT research) patient
care settings. We understand that there are many challenges
to the informed consent process in every day practice and
we hope this guide can improve the dialogue among various
professionals who have the responsibility to improve patients’
understanding of the complexities of their care. We see
this guide as a place to start and a mechanism to improve
this important dialogue. As you and your organization work
to improve your consent process, it is important to ensure
that your health care organization remains within both the
spirit and the letter of your state laws and institutional
policies related to informed consent. We understand all those
setting out to improve their informed consent practices
to work closely with their own legal counsels and risk managers.

Goal of this Guide

The goal of this publication is to help all those involved
in the informed consent process as it occurs in everyday
clinical practice (i.e., not in the research setting)
in order to improve the patient-physician communication
that is so crucial in creating truly informed patient
decision-making about major treatment options.

Lance Armstrong, the bicyclist who won 7 consecutive
Tour de France races, wrote a book called “It’s
Not About the Bike.” Just as Mr. Armstrong argues
so compellingly that worldclass cycling requires much
more than a good bike, high-quality informed consent
requires much more than a piece of paper to sign.
The form (like the bike) is obviously needed, but
much more is involved. This publication challenges
readers to consider all those other components that
contribute to adequate informed consent—including
the planning and the process for delivering and then
ensuring that the key messages have been truly received
and understood. The written form can definitely be
tuned up—and we offer specific tips for that—but
informed consent is actually a whole mindset and process
that needs to be continuously examined and improved
as a whole It’s not about the form!